• 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

• 2025-04-24 06:13:27

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

• 2025-04-24 07:49:13

The National Medical Products Administration has further adjusted and optimized certain provisions of the Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China, originally issued in September 2020.

• 2025-04-24 08:15:56

The National Medical Products Administration has organized and revised the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial Projects, which will come into effect on May 1, 2025.

• 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.

• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2025-03-25 09:14:44

South Korea's newly enacted Digital Medical Products Act (DMPA) establishes a dedicated regulatory framework for AI-driven devices, digital therapeutics, and health apps, ensuring their safety, effectiveness, and quality. Taking effect in January 2025, the Act introduces risk-based classifications, software and cybersecurity requirements, and clear pathways for digital health product approvals, positioning Korea as a global leader in digital health regulation.

• 2025-03-25 05:07:23

China's State Council has issued key amendments to the Regulations on the Supervision and Administration of Medical Devices. The updates broaden emergency use provisions and remove outdated institutional references—reflecting a push for stronger, more responsive regulatory governance in the health sector.

• 2025-03-10 02:22:15

Join Qualtech's webinar on March 26, 2025, for key insights into Australia's medical device market and TGA regulations. Learn about the registration process, Sponsor responsibilities, post-market requirements, and get answers to common questions. Register now here to secure your spot!

• 2025-02-21 05:38:28

Qualtech hosted a webinar providing key insights into the evolving European medical device regulations. The discussion covered essential updates, including the MDR transition period extension, Article 10A supply notification requirements, the gradual rollout of EUDAMED, the implications of the European AI Act, and regulatory changes in the UK and Switzerland. Attendees gained valuable guidance on compliance strategies and proactive measures to navigate these regulatory shifts.